CLASS II Device recall · Reported 30 Aug 2017 · FDA Enforcement Report
Vaser Amplifier, Vaser 2.2 VASERlipo System recalled by Solta Medical
Solta Medical is recalling Vaser Amplifier, Vaser 2.2 VASERlipo System, distributed in 7 states. The recall was initiated on 1 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3047-2017
- FDA event ID
- 77655
- Recalling firm
- Solta Medical, Bothell, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jun 2017
- FDA classified
- 21 Aug 2017
- Reported
- 30 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 1 Jun 2017 | Recall initiated by company | |
| 21 Aug 2017 | Classified by FDA | +81 days |
| 30 Aug 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
Product as listed by the FDA
VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
Where it was distributed
US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
Questions about this recall
Why was it recalled?
Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
Which lots are affected?
Reference No. 110-0021; Shipping P/N P007021-03; Device P/N P006982-03; Serial No. VAS10-0134, VAS13-0440, VAS12-0203, 000TWY.
Where was it sold?
US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 77655| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Vaser Pro Amplifier, Vaser 2.2 VASERlipo System stem recalled | Solta Medical | Labeling Errors | 7 states |
More recalls from Solta Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | thermage CPT System recalled by Solta Medical | Solta Medical | Other | MD |
| Device | CLASS II | Thermage Face Tip recalled by Solta Medical | Solta Medical | Other | 12 states |
| Device | CLASS II | Vaser Pro Amplifier, Vaser 2.2 VASERlipo System stem recalled | Solta Medical | Labeling Errors | 7 states |
| Device | CLASS II | Fraxel Dual 1550/1927 Laser System recalled by Solta Medical | Solta Medical | Other | CA |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |